tramadol hydrochloride

Generic: tramadol hydrochloride

Labeler: st. mary's medical park pharmacy
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tramadol hydrochloride
Generic Name tramadol hydrochloride
Labeler st. mary's medical park pharmacy
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tramadol hydrochloride 50 mg/1

Manufacturer
ST. MARY'S MEDICAL PARK PHARMACY

Identifiers & Regulatory

Product NDC 60760-588
Product ID 60760-588_3fa66c6a-130c-7945-e063-6294a90af0bd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202075
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2018-03-01

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60760588
Hyphenated Format 60760-588

Supplemental Identifiers

RxCUI
835603
UNII
9N7R477WCK

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tramadol hydrochloride (source: ndc)
Generic Name tramadol hydrochloride (source: ndc)
Application Number ANDA202075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 9 TABLET in 1 BOTTLE, PLASTIC (60760-588-09)
  • 20 TABLET in 1 BOTTLE, PLASTIC (60760-588-20)
  • 30 TABLET in 1 BOTTLE, PLASTIC (60760-588-30)
  • 50 TABLET in 1 BOTTLE, PLASTIC (60760-588-50)
  • 60 TABLET in 1 BOTTLE, PLASTIC (60760-588-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (60760-588-90)
  • 120 TABLET in 1 BOTTLE, PLASTIC (60760-588-92)
  • 180 TABLET in 1 BOTTLE, PLASTIC (60760-588-98)
source: ndc

Packages (8)

60760-588-09 9 TABLET in 1 BOTTLE, PLASTIC (60760-588-09) 60760-588-20 20 TABLET in 1 BOTTLE, PLASTIC (60760-588-20) 60760-588-30 30 TABLET in 1 BOTTLE, PLASTIC (60760-588-30) 60760-588-50 50 TABLET in 1 BOTTLE, PLASTIC (60760-588-50) 60760-588-60 60 TABLET in 1 BOTTLE, PLASTIC (60760-588-60) 60760-588-90 90 TABLET in 1 BOTTLE, PLASTIC (60760-588-90) 60760-588-92 120 TABLET in 1 BOTTLE, PLASTIC (60760-588-92) 60760-588-98 180 TABLET in 1 BOTTLE, PLASTIC (60760-588-98)

Ingredients (1)

tramadol hydrochloride (50 mg/1)

Linked Drug Pages (1)

tramadol hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3fa66c6a-130c-7945-e063-6294a90af0bd", "openfda": {"unii": ["9N7R477WCK"], "rxcui": ["835603"], "spl_set_id": ["087a7afe-ac1f-a201-e063-6394a90a260d"], "manufacturer_name": ["ST. MARY'S MEDICAL PARK PHARMACY"]}, "finished": true, "packaging": [{"sample": false, "description": "9 TABLET in 1 BOTTLE, PLASTIC (60760-588-09)", "package_ndc": "60760-588-09", "marketing_start_date": "20250312"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (60760-588-20)", "package_ndc": "60760-588-20", "marketing_start_date": "20240315"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (60760-588-30)", "package_ndc": "60760-588-30", "marketing_start_date": "20231006"}, {"sample": false, "description": "50 TABLET in 1 BOTTLE, PLASTIC (60760-588-50)", "package_ndc": "60760-588-50", "marketing_start_date": "20231006"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (60760-588-60)", "package_ndc": "60760-588-60", "marketing_start_date": "20240329"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (60760-588-90)", "package_ndc": "60760-588-90", "marketing_start_date": "20231006"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (60760-588-92)", "package_ndc": "60760-588-92", "marketing_start_date": "20250925"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (60760-588-98)", "package_ndc": "60760-588-98", "marketing_start_date": "20250312"}], "brand_name": "tramadol hydrochloride", "product_id": "60760-588_3fa66c6a-130c-7945-e063-6294a90af0bd", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "60760-588", "dea_schedule": "CIV", "generic_name": "tramadol hydrochloride", "labeler_name": "ST. MARY'S MEDICAL PARK PHARMACY", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tramadol hydrochloride", "active_ingredients": [{"name": "TRAMADOL HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA202075", "marketing_category": "ANDA", "marketing_start_date": "20180301", "listing_expiration_date": "20261231"}